Šalis: Naujoji Zelandija
kalba: anglų
Šaltinis: Medsafe (Medicines Safety Authority)
Ombitasvir 12.5mg; Paritaprevir 75mg; Ritonavir 50mg; Dasabuvir sodium monohydrate 270.26mg equivalent to dasabuvir 250 mg; ; Ribavirin 600mg;
AbbVie Limited
Ombitasvir 12.5 mg
Film coated tablet
Active: Ombitasvir 12.5mg Paritaprevir 75mg Ritonavir 50mg Excipient: Colloidal silicon dioxide Copovidone Opadry pink 85F140088 Propylene glycol monolaurate Sodium stearyl fumarate Sorbitan laurate Tocofersolan Active: Dasabuvir sodium monohydrate 270.26mg equivalent to dasabuvir 250 mg Excipient: Colloidal silicon dioxide Copovidone Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry beige 85F97497 Active: Ribavirin 600mg Excipient: Carnauba wax Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry blue 85F90623 Povidone
Prescription
AbbVie Ireland NL B.V.
Indicated for the treatment of genotype 1 chronic hepatitis C infection, including patients with compensated cirrhosis, HIV-1 coinfection, and liver transplant recipients. Duration of therapy and addition of ribavirin are dependent on patient population.
Package - Contents - Shelf Life: Blister pack, Ribavirin tablet. PVC/PCTFE/Al - 56 tablets - - Blister pack, Dasabuvir tablet. PVC/PE/PTCFE blister with an aluminium foil lidding. - 56 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, Ombitasvir/Paritaprevir/Ritonavir tablet PVC/PE/PTCFE blister with an aluminium foil lidding. - 56 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, Ribavirin tablet. HDPE bottle. - 56 tablets - 36 months from date of manufacture stored at or below 25°C - Combination pack, 28 daily Viekira Pak blister packs and 4 weekly Ribavirin blisters in a monthly carton - 168 tablets - 36 months from date of manufacture stored at or below 25°C - Combination pack, 28 daily combination blister packs in a monthly carton. 1 x monthly HDPE Bottle. - 168 tablets - 36 months from date of manufacture stored at or below 25°C
2014-07-15
VIEKIRA PAK-RBV CMI Version 10 August 2018 Page 1 _ _ VIEKIRA PAK-RBV _A COMBINATION THERAPY CONTAINING OMBITASVIR, PARITAPREVIR, RITONAVIR, _ _DASABUVIR AND RIBAVIRIN _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about VIEKIRA PAK- RBV. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT VIEKIRA PAK- RBV IS USED FOR VIEKIRA PAK-RBV is used to treat some types of chronic (long-lasting) hepatitis C in adults, including those with cirrhosis (scarring of the liver). Hepatitis C is a liver disease caused by a virus, which infects and damages liver cells. This treatment consists of three different types of tablets for patients with hepatitis C. These must be taken according to the instructions given by your doctor. VIEKIRA PAK-RBV includes medicines called direct-acting antiviral agents, and also includes ribavirin to treat your HCV infection. It works by by lowering the amount of hepatitis C virus in your body. It removes the virus from your blood over a period of time. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another purpose. This medicine is only available with a doctor’s prescription. BEFORE YOU TAKE VIEKIRA PAK-RBV _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE VIEKIRA PAK-RBV IF YOU HAVE AN ALLERGY TO: ANY MEDICINE CONTAINING OMBITASVIR, PARITAPREVIR, RITONAVIR, DASABUVIR OR RIBAVIRIN ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET Some symptoms of an allergic reaction include hives, skin rash or itching of the skin shortness of breath, wheezing, difficulty breathing Perskaitykite visą dokumentą
VIEKIRA PAK-RBV Version 14 16 August 2018 1 of 65 NEW ZEALAND DATA SHEET 1. VIEKIRA PAK-RBV (RIBAVIRIN 200 MG) VIEKIRA PAK-RBV (RIBAVIRIN 400 MG)* VIEKIRA PAK-RBV (RIBAVIRIN 1000 MG)* VIEKIRA PAK-RBV (RIBAVIRIN 1200 MG)* VIEKIRA PAK-RBV is a composite pack containing ombitasvir/paritaprevir/ritonavir 12.5/75/50 mg tablets copackaged with dasabuvir 250 mg tablets, and 200 mg, 400 mg* or 600 mg* ribavirin tablets. * Presentation not currently available in New Zealand. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each co-formulated ombitasvir/paritaprevir/ritonavir film-coated tablet contains 12.5 mg of ombitasvir, 75 mg of paritaprevir and 50 mg of ritonavir. For the full list of excipients, see section 6.1. Each dasabuvir film-coated tablet contains 250 mg of dasabuvir (as sodium monohydrate). Excipient with known effect: Each film-coated tablet contains 44.94 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. Each ribavirin film-coated tablet contains 200 mg, 400 mg* or 600 mg* of ribavirin. * Presentation not currently available in New Zealand. Excipient with known effect: Each 200 mg film-coated tablet contains 15 mg lactose (as monohydrate). Each 400 mg film-coated tablet contains 30 mg lactose (as monohydrate). Each 600 mg film-coated tablet contains 45 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. VIEKIRA PAK-RBV Version 14 16 August 2018 2 of 65 3. PHARMACEUTICAL FORM Ombitasvir/paritaprevir/ritonavir 12.5/75/50 mg tablets are pink-coloured, film-coated, oblong biconvex shaped, debossed with “AV1” on one side. Dasabuvir 250 mg tablets are beige-coloured, film-coated, oval-shaped, debossed with “AV2” on one side. Ribavirin 200 mg tablets are light-blue, film-coated, oblong-shaped and debossed with “200” on one side and “3RP” on the other side. Ribavirin 400 mg tablets are blue, film-coated, oblong-shaped and debossed with “400” on one side and “3RP” on the other side*. Ribavirin 600 mg tablets are deep-blue, film-coated, oblo Perskaitykite visą dokumentą